First In-Ear EEG Device Gets FDA Clearance

 The FDA cleared an electroencephalography (EEG) system based on a small sensor worn in the ear, allowing patients to be monitored outside of hospital settings, Naox Technologies in Paris, announced on Tuesday.

The Naox Link in-ear EEG platform is the first of its kind to be cleared for prescription use at home or in healthcare settings, the company said. It uses wired earbuds with electrodes on the tips to acquire, record, and transmit one channel of EEG data.

"EEG readings have traditionally been constrained by short recording windows, uncomfortable headgear, and clinical settings that fail to reflect patients' real lives," Naox co-founder and CEO Hugo Dinh said in a press release. "With FDA clearance of Naox Link, clinicians can extend EEG into everyday environments, enabling longer, repeated more natural recordings and opening new possibilities for understanding brain activity beyond the clinic."

The Naox Link system received 510(k) clearance and is intended for adult and pediatric patients ages 6 years and older. It does not provide automated diagnostic conclusions and marks a new category of ambulatory EEG for neurology, sleep medicine, and research, the company said.

"By moving EEG acquisition from bulky scalp electrodes and gel-based setups to a comfortable in-ear format, Naox Link enables clinicians to capture brain activity during everyday life, sleep, daily routines, and real-world conditions that are often missed during traditional 20-30 minute in-clinic EEG sessions," the company stated.

Several studies have explored the benefits and limitations of in-ear EEG. One that compared the signal quality of in-ear EEG with dry electrodes versus a conventional EEG cap system with 64 wet electrodes supported the feasibility of using in-ear EEG devices for brain activity monitoring, especially for wakefulness and sleep uses.

Hospital EEG is mainly efficient for disease diagnosis, noted Naox advisor Gilles Huberfeld, MD, PhD, of the Rothschild Foundation Hospital in Paris. "A comfortable in-ear system that works overnight and at home opens an entirely new window into brain function, one that may improve detection, monitoring, and understanding of neurological conditions," Huberfeld said in a statement. "To be one step ahead of disease is a fantasy in medicine, even more so in neurology, and capturing the brain's long-term dynamics is the first prerequisite."

Naox is collaborating with European institutions, including Necker Hospital in Paris and the Rothschild Foundation Hospital, to conduct studies of pediatric epilepsy and focal epilepsies of adult patients and epileptiform activity in patients at risk of Alzheimer's disease. The company plans to expand clinical partnerships in the U.S.

Naox also offers a wireless in-ear consumer device designed for general wellness insights called the Naox Wave. Naox Wave is not cleared by the FDA and is not intended for medical use.

https://www.medpagetoday.com/neurology/generalneurology/119305